Short answer: Low blood sugar (hypoglycemia) is the most common side effect of Semglee and other insulin glargine products. In the insulin glargine studies on the label, upper respiratory infection affected 22.4% of adults with type 1 diabetes (23.1% on NPH insulin) and 11.4% with type 2 (13.3% on NPH). Injection site pain affected 2.7% (0.7% on NPH). Semglee has no boxed warning.
What Semglee is approved for: Semglee is a long-acting insulin approved to improve blood sugar control in adults and children with diabetes (section 1). It is not recommended for treating diabetic ketoacidosis.
Source
SEMGLEE (insulin glargine-yfgn) injection, for subcutaneous use, prescribing information, Patient Information and Instructions for Use. Biocon Biologics. DailyMed, version published April 17, 2026. DailyMed setid 8cf5544f-87d6-468b-f6ae-898b1fdb5d80
No. The current Semglee label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Semglee.
| Adverse reaction | Insulin glargine, % (n=1257) | NPH, % (n=1070) |
|---|---|---|
| Upper respiratory tract infection | 22.4 | 23.1 |
| Infection | 9.4 | 10.3 |
| Accidental injury | 5.7 | 6.4 |
| Headache | 5.5 | 4.7 |
Insulin glargine studies against NPH insulin, as printed on the Semglee label. "Infection" is body system not specified.
| Adverse reaction | Insulin glargine, % (n=849) | NPH, % (n=714) |
|---|---|---|
| Upper respiratory tract infection | 11.4 | 13.3 |
| Infection | 10.4 | 11.6 |
| Retinal vascular disorder | 5.8 | 7.4 |
| Adverse reaction | Insulin glargine, % (n=514) | NPH, % (n=503) |
|---|---|---|
| Upper respiratory tract infection | 29.0 | 33.6 |
| Edema peripheral | 20.0 | 22.7 |
| Hypertension | 19.6 | 18.9 |
| Influenza | 18.7 | 19.5 |
| Sinusitis | 18.5 | 17.9 |
| Cataract | 18.1 | 15.9 |
| Bronchitis | 15.2 | 14.1 |
| Arthralgia | 14.2 | 16.1 |
| Pain in extremity | 13.0 | 13.1 |
| Back pain | 12.8 | 12.3 |
| Cough | 12.1 | 7.4 |
| Urinary tract infection | 10.7 | 10.1 |
| Diarrhea | 10.7 | 10.3 |
| Depression | 10.5 | 9.7 |
| Headache | 10.3 | 9.3 |
| Adverse reaction | Insulin glargine, % (n=174) | NPH, % (n=175) |
|---|---|---|
| Infection | 13.8 | 17.7 |
| Upper respiratory tract infection | 13.8 | 16.0 |
| Pharyngitis | 7.5 | 8.6 |
| Rhinitis | 5.2 | 5.1 |
| Study | Insulin glargine, % | NPH or standard care, % |
|---|---|---|
| Study A, type 1 adults, 28 weeks, with regular insulin | 10.6 | 15.0 |
| Study B, type 1 adults, 28 weeks, with regular insulin | 8.7 | 10.4 |
| Study C, type 1 adults, 16 weeks, with insulin lispro | 6.5 | 5.2 |
| Study D, type 1 children, 26 weeks, with regular insulin | 23.0 | 28.6 |
| Study E, type 2 adults, 52 weeks, with oral agents | 1.7 | 1.1 |
| Study F, type 2 adults, 28 weeks, with regular insulin | 0.4 | 2.3 |
| Study G, type 2 adults, 5 years, with regular insulin | 7.8 | 11.9 |
| ORIGIN, 6.2 years (glargine n=6231, standard care n=6273) | 5.6 | 1.8 |
Severe meant symptoms needing another person's help, with blood glucose below 50 mg/dL (56 or less in the 5-year study, 36 or less in ORIGIN) or prompt recovery after carbohydrate, IV glucose or glucagon.
In adult studies, injection site pain was reported in 2.7% on insulin glargine and 0.7% on NPH insulin; it did not lead anyone to stop treatment. Other injection site reactions included redness, itching, hives, swelling and inflammation.
Rapid improvement in blood sugar has been linked to a temporary, reversible vision refraction change, worsening of diabetic retinopathy and acute painful nerve pain. Weight gain, swelling from sodium retention and skin pits or thickening (lipodystrophy) can also occur.
All insulins can cause insulin antibodies, which may raise or lower insulin's effect. In insulin glargine studies, antibody increases happened at similar rates on glargine and NPH insulin.
Reported after approval: rapid-acting and other insulins given by mistake instead of insulin glargine; and localized cutaneous amyloidosis (lumps under the skin) at injection sites, which has affected blood sugar control.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Semglee is not used during an episode of low blood sugar, or by people allergic to insulin glargine products or its ingredients.
Never share a pen, syringe or needle. A Semglee pen is never shared, even if the needle is changed, and vial users never re-use or share needles or syringes, because of the risk of passing on blood-borne infections.
Changes in insulin regimen. Changing insulin strength, maker, type, injection site or method can cause high or low blood sugar, so changes are made under close medical supervision with more glucose checks.
Low blood sugar. Hypoglycemia is the most common reaction to insulin, and severe episodes can cause seizures or death. The long action of insulin glargine may delay recovery from a low. Awareness of lows may be reduced with long diabetes, nerve damage, beta-blockers or repeated lows.
Medication mix-ups. Mix-ups among insulin products have been reported, so the insulin label is checked before each injection.
Serious allergic reactions. Severe, life-threatening whole-body allergy, including anaphylaxis, can occur; Semglee is stopped if it does.
Low potassium. All insulins shift potassium into cells and can cause low potassium, which untreated can cause breathing paralysis, heart rhythm problems and death.
Heart failure with TZDs. Thiazolidinediones (such as pioglitazone) with insulin can cause fluid retention that may lead to or worsen heart failure.
From the Patient Information that comes with Semglee:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.